Medical device manufacturer, Maquet Cardiopulmonary GmbH, issued a medical device safety alert concerning its HCU 40 Heater-Cooler Unit [70104.4054 Heater-Cooler Unit HCU 40 High Voltage & 70105.4917 Heater-Cooler Unit HCU 40 Low Voltage].
The manufacturer globally has received complaints for the HCU 40 Heater-Cooler Unit about ice melting in relation to 3-way-valve malfunctions. Statistical analysis indicates that with increasing operation time of the HCU 40 device the probability of the 3-way-valve to malfunction increases. To significantly reduce the probability of 3-way valve malfunction, the manufacturer is initiating a preventive field action for the annual exchange of the HCU 40 3-way-valves during the regular maintenance.
The HCU 40 Heater-Cooler Unit is intended for cooling or warming a patient connected to the extracorporeal perfusion circuit and keeping the required patient temperature constant. The system comprises two separate water circuits with temperature regulation. The first circuit is for connecting the oxygenator heat exchanger and/or the warming/cooling blanket. The second circuit is intended for connecting the cardioplegia heat exchanger. Both water circuits of the HCU 40 feature multiple valves that control the water flow. The 3-way valves regulate the balance of warm and cold water circulated in both, the patient and cardioplegia water circuits.
According to the manufacturer, 3-way-valve failures were predominately detected during service.
Due to the direction of water flow through the 3-way-valve, the heating performance of the HCU 40 is not impacted and patient warming is therefore not affected by a 3-way-valve malfunction. The manufacturer has not received any complaints of patient harm, serious injuries or deaths caused by a HCU 40 3-way-valve malfunction.
The manufacturer is taking the following actions:
The manufacturer is instructing affected users to follow the HCU 40 Instructions for Use to prevent incidences related to HCU 40 3-way-valve malfunctions, especially
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Aug 2021